Allogeneic Umbilical Cord Blood Therapy in Children With CP

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This open-label study aims to analyze cytokines related to clinical outcomes of allogeneic umbilical cord blood therapy for children with cerebral palsy.

Condition or disease

Intervention/treatment

Cerebral Palsy

Procedure: Allogeneic umbilical cord blood therapy

Detailed Description:

Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) may be used as restorative approach for children with CP.

Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries.

Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP. This study was designed to find cytokines relevant to UCB therapy.

WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher score means more independent performance in daily activities.

Number of adverse events and participants with those adverse events [ Time Frame: 12 months ]

The numbers of adverse events and subjects with those serious adverse events within each group; A serious adverse event is any untoward medical occurrence that at any dose: results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or causes a congenital anomaly/birth defect.

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Ages Eligible for Study:

up to 15 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosed with cerebral palsy

Age of ≤15 years

Mismatch in HLA-A, B, and DR ≤2, and total nucleated cell count ≥3x10^7/kg. If the cell count is less than given values, more than 1 unit could be used.

Decision of participation in the study by and acquisition of informed consent from the subject's representative

Willingness and ability to be hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry

Exclusion Criteria:

Current aspiration pneumonia

Known genetic disease

History of hypersensitivity reaction to any study drugs pertinent to the study

Patient with severe seizure disease who has clinical convulsion despite combination therapy with 3 or more agents